Status: On track towards GMP certification of Host Cell Protein analysis

1 February 2022

Our team has worked for more than eight years to develop a robust method and solve the challenges related to the MS analysis of HCPs.

By now, we have used the assay in more than 200 customer projects, and we have worked passionately to make the test results easy to understand and use.

We are excited to report that the Danish Health Authorities have been on inspection and only had minor observations. Thus, we expect to receive our certificate to work under GMP conditions according to FDA and EMA regulations, by the end of this quarter.

Update 13 March: Today, we received the formal approval letter and are thus now able to carry out work under GMP.